"A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Na\u00EFve Metastatic Castration-Resistant Prostate Cancer"@en . "Randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, multicentrick\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 porovn\u00E1vaj\u00EDc\u00ED kombinaci Orteronel (TAK-700) a prednison s kombinac\u00ED placebo a prednison u pacient\u016F s kastra\u010Dn\u011B rezistentn\u00EDm metastatick\u00FDm karcinomem prostaty, kte\u0159\u00ED dosud nebyli l\u00E9\u010Deni chemoterapi\u00ED" . "Randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, multicentrick\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 porovn\u00E1vaj\u00EDc\u00ED kombinaci Orteronel (TAK-700) a prednison s kombinac\u00ED placebo a prednison u pacient\u016F s kastra\u010Dn\u011B rezistentn\u00EDm metastatick\u00FDm karcinomem prostaty, kte\u0159\u00ED dosud nebyli l\u00E9\u010Deni chemoterapi\u00ED"@cs . "Randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, multicentrick\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 porovn\u00E1vaj\u00EDc\u00ED kombinaci Orteronel (TAK-700) a prednison s kombinac\u00ED placebo a prednison u pacient\u016F s kastra\u010Dn\u011B rezistentn\u00EDm metastatick\u00FDm karcinomem prostaty, kte\u0159\u00ED dosud nebyli l\u00E9\u010Deni chemoterapi\u00ED" . "1"^^ . . . "Hlavn\u00EDm c\u00EDlem studie Zjistit, zda orteronel plus prednison zvy\u0161uje radiografick\u00E9 p\u0159e\u017Eit\u00ED bez progrese (rPFS) Zjistit, zda orteronel plus prednison zlep\u0161uje celkov\u00E9 p\u0159e\u017Eit\u00ED (OS) Sekund\u00E1rn\u00ED c\u00EDle studie Zjistit, zda orteronel plus prednison zvy\u0161uje 50% prostatick\u00FD specifick\u00FD antigen (PSA) po 12 t\u00FDdnech l\u00E9\u010Dby Vyhodnotit zm\u011Bny v cirkuluj\u00EDc\u00EDch n\u00E1dorov\u00FDch bu\u0147k\u00E1ch (CTC) Posoudit, zda orteronel zkracuje dobu do progrese bolesti"@cs . . . . "N" . . . "PPD Czech Republic, s.r.o." . "Hlavn\u00EDm c\u00EDlem studie Zjistit, zda orteronel plus prednison zvy\u0161uje radiografick\u00E9 p\u0159e\u017Eit\u00ED bez progrese (rPFS) Zjistit, zda orteronel plus prednison zlep\u0161uje celkov\u00E9 p\u0159e\u017Eit\u00ED (OS) Sekund\u00E1rn\u00ED c\u00EDle studie Zjistit, zda orteronel plus prednison zvy\u0161uje 50% prostatick\u00FD specifick\u00FD antigen (PSA) po 12 t\u00FDdnech l\u00E9\u010Dby Vyhodnotit zm\u011Bny v cirkuluj\u00EDc\u00EDch n\u00E1dorov\u00FDch bu\u0147k\u00E1ch (CTC) Posoudit, zda orteronel zkracuje dobu do progrese bolesti" . "Zachoval, Roman" . . "RIV/00064190:_____/13:#0000737" . . "Praha" . "RIV/00064190:_____/13:#0000737!RIV14-MZ0-00064190" . . "Main objective of the trial To determine if orteronel plus prednisone improves Radiographic Progression-Free Survival (rPFS) To determine if orteronel plus prednisone improves Overall Survival (OS) Secondary objectives of the trial To determine if orteronel plus prednisone improves 50% Prostate-Specific Antigen (PSA) response at 12 weeks To evaluate changes in Circulating Tumor Cell (CTC) counts To evaluate whether orteronel improves time to pain progression"@en . "[A51FA9875DD3]" . . "Randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, multicentrick\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 porovn\u00E1vaj\u00EDc\u00ED kombinaci Orteronel (TAK-700) a prednison s kombinac\u00ED placebo a prednison u pacient\u016F s kastra\u010Dn\u011B rezistentn\u00EDm metastatick\u00FDm karcinomem prostaty, kte\u0159\u00ED dosud nebyli l\u00E9\u010Deni chemoterapi\u00ED"@cs . "Chemotherapy"@en . . . "3"^^ . "A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Na\u00EFve Metastatic Castration-Resistant Prostate Cancer"@en . "1"^^ . "101440" .